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Can estrogen patches strengthen bones in anorexia?

NCT ID NCT03875378

Disease control Sponsor: Pouneh K. Fazeli, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether a skin patch that delivers estrogen can help improve bone density in adult women with anorexia nervosa who have low bone mass. Participants will be randomly assigned to receive either the estrogen patch or a placebo patch for 18 months. The main goal is to see if the treatment increases bone mineral density in the spine.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2020

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female 2. 19-45 years of age 3. DSM-5 psychiatric criteria for anorexia nervosa 4. \<85% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables 5. Amenorrhea 6. T-score of \< -1.0 at spine or hip Exclusion Criteria: 1. Diseases known to affect bone metabolism, including untreated thyroid dysfunction, vitamin D deficiency, Cushing's syndrome, diabetes mellitus or renal insufficiency (eGFR \< 60) 2. Personal history of venous or arterial clot 3. History of stroke or myocardial infarction 4. History of hypercoagulable disorder 5. Personal history or history of a first-degree relative with breast cancer 6. History of hereditary angioedema 7. Any medication known to affect bone metabolism, including systemic glucocorticoids within three months of the baseline visit, depot medroxyprogesterone within 6 months of the baseline visit, oral bisphosphonates within one year of the baseline visit or IV bisphosphonates within three years of the baseline visit 8. Bone fracture within the prior 12 months 9. Serum potassium \< 3.0 meq/L, serum ALT \> 3 times the upper limit of normal or Hemoglobin \< 10 g/dL 10. Fasting serum triglyceride level \> 150 mg/dL 11. Pregnant or breastfeeding (or desiring pregnancy within the next 18 months) 12. Active substance abuse 13. Elevated PTH level 14. 25-OH vitamin D level \< 20 ng/mL 15. Low phosphorus level

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Conditions

The condition(s) this trial relates to.

anorexia nervosa

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anorexia nervosa

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Pittsburgh School of Medicine

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

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